Unified Business No.

80315489

Industry

Other Manufacturing (2,432)

Main products

Other fabricated metal products (10,961)

Location

No. 12, Keyuan 2nd Rd., Xitun Dist., Taichung City 40763, Taiwan (R.O.C.)↗
Taichung City (17,121) · Xitun Dist. (804)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2003-04-18

Paid-in capital

NT$ 221,000,000

Representative

Chuang Sheng-hsiung

Phone

(04)24636275

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Compliance record

FDA import refusal: 1 product(s), latest 2024-08-29

Plants 2

• Plant · No. 12, Keyuan 2nd Rd. (Central Taiwan Science Park), Xitun Dist., Taichung City↗ In production
• Zhonggong Plant · No. 12-5, Gongyequ 31st Rd., Xitun Dist., Taichung City↗ In production

Certifications 10

• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-11-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-11-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-10-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-26 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 10

• FDA 510(k) clearance K242814 2024-11-14
  Tandry Q-Locking Plate System
• FDA 510(k) clearance K230690 2023-08-17
  Tandry Locking Plate System
• FDA 510(k) clearance K220360 2022-11-10
  Tandry CMF Plate System
• FDA 510(k) clearance K220359 2022-09-20
  Tandry Compression Screw System
• FDA 510(k) clearance K182929 2019-11-06
  BIO-RAY A-1 Anchor Screw System
• FDA 510(k) clearance K171904 2018-09-18
  Tandry Locking Plate System
• FDA 510(k) clearance K111008 2012-05-02
  MICROWARE BONE PLATES AND BONE SCREW
• FDA 510(k) clearance K072562 2008-12-04
  MICROWARE BONE PLATES AND BONE SCREWS
• FDA medical device registration 3007738812 2009-03-02 – 2026-03-17
  Screw, Fixation, Bone; Plate, Bone; Plate, Fixation, Bone and more (24)
• FDA import refusal 3012617125 2024-08-29
  IMPLANT, ENDOSSEOUS, ORTHODONTIC

Similar companies 10

• NORTH EOS INDUSTRIES INC. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• AEON BIOTHERAPEUTICS CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• TOP SURGICAL TAIWAN CORPORATION · Kaohsiung City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• HONG TSUN TRADING CO. · Kaohsiung City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Household optical products retail
• E-Care Technology Co., Ltd. · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c., Electronic equipment wholesale
• SANCARE HEALTH CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH · Hsinchu City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• APLAN WELL ENTERPRISE CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical chemical products manufacturing n.e.c.
• FOUNTAIN MEDICAL EQUIPMENTS CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II)
• HONG SHIANG TECHNOLOGY CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Electronic equipment wholesale

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